ValiRx Regulatory News (VAL)

14 May 2015

ValiRx Plc

("ValiRx" or "the Company")

ValiSeek Development Update - completion of pre-clinical studies

ValiRx Plc (AIM: VAL), the life science company with a focus on cancer diagnostics and therapeutics for personalised medicine, is pleased to provide a development update on the progress of pre-clinical studies at ValiSeek Limited ("ValiSeek") on the first anniversary of the joint venture between ValiRx and Tangent Reprofiling Limited.

ValiSeek was formed to progress the novel cancer treatment drug, VAL401, towards Clinical Efficacy trials for the treatment of lung cancer and other oncology indications.

Further to the Company's update on 15 January 2015, ValiSeek reports on the completion of its pre-clinical toxicology and pharmacokinetic studies.

Preclinical efficacy of VAL401 in the treatment of adenocarcinoma tumours has been confirmed in pancreatic and non-small cell lung cancer models in addition to the prostate cancer models previously run by Tangent. The newly reported pancreatic data shows VAL401 to demonstrate comparable anti-tumour activity to clinical drug Gemcitabine in an adenocarcinoma model. As a further area of high unmet medical need, this additional data in pancreatic cancer enhances the overall commercial value of the VAL401 project.

Preclinical toxicology and pharmacokinetic studies have been completed to the required regulatory standards confirming safety, tolerability, distribution and metabolism of VAL401 as comparable to the conventionally formulated clinical active drug. This ensures the prior clinical data can be included as supporting information in regulatory submission packages without further safety studies.

Prototype manufacturing of encapsulated VAL401 in the oral clinical format has been completed and formal stability studies are underway.

Clinical-based regulatory planning and the process has commenced with a first Science Advisory Meeting taking place between ValiSeek and the Medicines and Healthcare Products Regulatory Agency ("MHRA") in late February 2015. This meeting introduced the MHRA panel of scientific assessors to the VAL401 project, thereby initiating the regulatory process and ensuring a smooth set-up of the appropriate late stage clinical trial.

2015 BIO International Convention

Along with parent company ValiRx Plc, ValiSeek has been invited to join the UK trade visit to the 2015 BIO International Convention in Philadelphia, Pennsylvania (14-18 June 2015). As detailed in ValiRx's announcement of 30 April 2015, "The Market Visit" has been organised by the Mayor of London's Export Programme, in partnership with UK Trade & Investment (UKTI) to offer London SMEs an opportunity to attend this major industry international event and a chance to partner with the world's leading pharmaceutical and biotechnology companies.

Dr Suzanne Dilly, CEO of ValiSeek Limited, commented: "With clinical-based regulatory planning and documentation now commencing for VAL401, I look forward to the formal clinical trial application progressing according to schedule and building further momentum."

Dr Satu Vainikka, CEO of ValiRx plc, added: "The ValiSeek drug development is moving forward well and we are very pleased to see VAL401's move into the clinic."

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Notes for Editors

About ValiSeek

ValiSeek Limited ("ValiSeek") is a joint venture ("JV") company between ValiRx Plc and Tangent Reprofiling Limited, part of the SEEK Group. ValiSeek was formed to progress the drug VAL401 through its remaining preclinical development and towards Phase II trials for the treatment of lung cancer and other oncology indications

About SEEK

Founded in 2004, SEEK (previously known as PepTcell) is privately owned and funded, with headquarters in London, UK. SEEK brings safe and low costs medicines to the patients as quickly as possible. It does this by modifying existing medicines to improve their efficacy within current label, dose and regime, by changing the indication but keeping the dose and dosing regime the same or by creating a new medicine when the previous options are unavailable.

Additional information about SEEK is available on the Company's website located at www.seekacure.com

ValiRx Plc

ValiRx Plc is a biopharmaceutical company developing novel technologies and products in oncology therapeutics and diagnostics. The product focus is in the epigenomic analysis and treatment of cancer, but the technologies can be applied to other fields as well, such as neurology and inflammatory diseases.

The Company has undertaken to develop a novel and groundbreaking class of therapeutics across a number of fields in oncology and has taken its lead compound, Val201, into Phase I/II clinical trials. The Company listed on the Alternative Investment Market ("AIM") of the London Stock Exchange in October 2006.

The Company has a pipeline of other therapeutic drugs, which are currently progressing towards clinical trials. The product focus is in the targeted analysis and treatment of cancer, but the technologies can be applied to other fields as well, such as neurology and inflammatory diseases.

It actively manages projects within its portfolio as a trading company. The ValiRx business model spreads the risks of life science technology development by minimising financial exposure and running a set of projects to defined commercial endpoints. This maximises returns to shareholders by adding value at the earlier stages where value increases per investment unit are the greatest.

The Company operates through the following divisional companies:

1. ValiPharma is the therapeutics division, with two embedded technologies primarily directed at the treatment of cancers.

2. ValiFinn is the biomarkers and diagnostic development division. ValiRx acquired through its ValiFinn subsidiary, the complimentary TRAC technology later in the year to strengthen the portfolio.

3. ValiSeek is a joint venture between ValiRx and Tangent Reprofiling Ltd to develop Val401 in lung cancer and potentially other indications.